Devices

Device Recall Nasal Splint

  • Modèle / numéro de série
    All Lots of alcohol pad supplied in the following kits:  REF: 1528116 (sm):  29435400 56546900 59577800 62129000 64918600 51350700 56622000 59748100 62491500 65206800 53799600 57312400 59887500 62647600 65482100 54038700 57520700 60156800 62892100 66033700 54597800 57540700 60494800 63137800 66336700 54991100 57676700 60708300 63481200 66814000 55301000 58005700 61032000 63707800 67838900 55610900 58188100 61532100 63937700 67940600 56072200 58970000 61888600 64257500 68658000 56229700 59328700 61938500 64615900 68918600.   REF 1528126 (med):  36361500 54818200 58360300 62548400 65917800 43037100 54863900 58646400 62821300 66124900 44818300 55151800 58687600 63159400 66474100 45129900 55242200 59075900 63338600 66933800 50667000 55409500 59619200 63519800 67255300 51270000 56072400 59886900 63852400 67577700 52341200 56307900 60519300 63852600 67815500 52669500 56546500 61026800 64144700 67877800 53120100 56893600 61241400 64615400 67878000 53381200 57094500 61419000 64758400 68567600 53712500 57637600 61905500 64863900 68935700 53799500 57943700 61938600 65206000 68959300 54501300 58004000 62293100 65206100.   REF 1528136 (lg):  31477100 54817800 59328800 61888900 65482000 39187500 54863300 59513800 62295000 65671400 44987900 54905400 59747800 62704800 66288600 51897300 56309000 59887200 62821400 66996400 52303000 56372500 60113000 63475900 67081600 52801000 56495500 60225500 63775400 67814800 52981200 57312500 60494500 64332900 68534100 53158900 57385900 60513700 64625000 68823100 53711700 58189000 61026400 64748800 68843200 53800300 58970100 61359800 64918100  53896300 59076300 61639600 65206900.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.
  • Description du dispositif
    An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1528116***External Nasal Splint Kit, Small***X5***. || ***REF 1528126***External Nasal Splint Kit, Medium***X5***. || ***REF 1528136***External Nasal Splint Kit, Large***X5***. || RECALLED PRODUCT - Front: || ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. || RECALLED PRODUCT - Back: || ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.*** || Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event

Fabricant

Medtronic Xomed, Inc.
  • Adresse du fabricant
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall Nasal Splint
  • Modèle / numéro de série
    All Lots of alcohol pad supplied in the following kits:  REF: 1529100 (sm):  35264300 56072300 59748000 63338900 67148300 45672700 56229600 59887300 63390900 67187000 46559700 56893700 60114300 63594300 67255600 52740600 57094300 60494400 63937800 67685400 53030400 57501500 60748000 64257100 67732700 53120200 57637900 61031000 64617300 68011400 53593000 57943500 61417800 64917800 68051600 53799400 58177600 61903200 65072500 68124600 53960600 58414100 62128800 65482200 68214500 55026000 58969400 62487300 65723200 68779200 55301100 58971000 62988600 66033900  55746000 59329100 63138100 66102500.   REF: 1529110 (med):  32765300 55409300 59620200 62294300 65332500 36977500 55610700 59747600 62451300 65629400 45275000 55846300 59826600 62486600 65836900 45672800 56071000 60114100 62849200 65954400 46725100 56308700 60156500 62892000 66006700 51269600 56546300 60225400 63075400 66187600 53119700 56840300 60494300 63265400 66259300 53304100 56978500 60495500 63339200 66434800 53411800 57166400 60514000 63391000 66521600 53423800 57341200 60747600 63475600 67071500 53938600 57501400 60840900 63772200 67326300 53962000 57676800 61030800 63852800 67500900 54038800 58187700 61417600 63937600 67873100 54359500 58969000 61570900 64257400 68657800 54597900 59076100 61639500 64333000 68842900 54864100 59291100 61858800 64918000  54905500 59513600 62128600 65139000.   REF 1529120 (lg):  46873800 54863800 58189400 61906500 64918400 47201900 55409700 58970200 62128900 65481900 51303300 55801200 59076400 62451600 65671500 52930000 55846600 59577300 62491600 66034500 53064800 56231100 59826300 63076000 66684000 53158700 56546800 60156900 63176600 68873800 53353000 56893800 60494200 63390800  53800000 57094000 60748100 63475700  54170800 57501200 61031400 63708700  54352600 58177900 61639100 64332700
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.
  • Description du dispositif
    Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1529100***Thermasplint Kit, Small***X5***. || ***REF 1529110***Thermasplint Kit, Medium***X5***. || ***REF 1529120***Thermasplint Kit, Large***X5***. || RECALLED PRODUCT - Front: || ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. || RECALLED PRODUCT - Back: || ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***
  • Manufacturer
    Medtronic Xomed, Inc.